BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1021283 · Received March 25, 2008

    Report

    Report Number
    9616099-2008-00784
    Event Type
    Injury
    Date Received
    March 25, 2008
    Date of Event
    July 1, 2007
    Report Date
    March 3, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED. IT IS ALSO NOT AVAILABLE FOR TESTING AND EVALUATION. ADD'L INFO RECEIVED WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED BY THE STUDY, APPROXIMATELY 6 3/4 WEEKS AFTER PERCUTANEOUS CORONARY INTERVENTION (PCI), THE PT HAD A NON Q-WAVE MYOCARDIAL INFARCTION AT AN UNDETERMINED LOCATION. IT WAS ALSO UNDETERMINED IF IT WAS TARGET VESSEL RELATED. CK-MD WAS GREATER THAN 5 TIMES ABOVE THE UPPER NORMAL LIMITS AND TROPONIN WAS 2 TIMES ABOVE THE UPPER NORMAL LIMITS. THERE WAS NO EVIDENCE OF STENT THROMBOSIS. IT DID NOT REQUIRE REPEAT PCI. HOWEVER, THE PT HAD UNSTABLE ANGINA PRIOR TO THE ACUTE MYOCARDIAL INFARCTION (AMI), WHICH RESULTED IN CORONARY ANGIOGRAPHY. ANGIOGRAPHY SHOWED 0% STENOSIS IN THE MID LAD WITH TIMI III FLOW. IN THE PROXIMAL LAD STENT, THERE WAS 70% PROXIMAL PERI-STENT RESTENOSIS. THERE WAS NO EVIDENCE OF AN ANEURYSM. AFTER THE AMI, FIVE DAYS LATER, THE PT HAD A CORONARY ARTERY BYPASS GRAFT (CABG) FROM THE LIMA TO THE DIAGONAL. THIS PT PRESENTED TO THE CARDIAC CATHETERIZATION UNIT AND 1-VESSEL DISEASE WAS FOUND. TWO LESIONS WERE TREATED DURING THE PROCEDURE. THE PRIMARY INDICATION FOR INTERVENTION WAS SILENT ISCHEMIA AS EVIDENCED BY ECG STRESS TEST (BICYCLE/TREADMILL). PRE-PROCEDURE TROPONIN WAS WITHIN NORMAL LIMITS. THE PT'S BLOOD PRESSURE AT THE BEGINNING OF THE PROCEDURE WAS 150/100. THE HEART RATE WAS 75 AND THE LEFT VENTRICLE EJECTION FRACTION (LVEF) WAS GREATER THAN 50%. PRE-PROCEDURE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL, STATINS, OTHER LIPID LOWERING MEDICATIONS AND BETA-BLOCKERS. INTRA-PROCEDURE MEDICATIONS INCLUDED CLOPIDOGREL AND UNFRACTIONATED HEPARIN. PCI WAS PERFORMED ON A 75% DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) OF 22MM IN LENGTH IN A 2.5MM VESSEL DIAMETER. THE (B1) CONCENTRIC LESION WAS CHARACTERIZED WITH A SMOOTH CONTOUR, MODERATE CALCIFICATION AND THROMBUS ABSENT. THE LESION WAS PRE-DILATED WITH A 2.5 X 20MM AT 12 ATMOSPHERES (ATM) BEFORE A 2.5 X 23MM CYPHER SELECT PLUS STENT WAS DEPLOYED AT 12 ATM WITH SATISFACTORY RESULTS. POST-DILATATION WAS DONE WITH A 2.75X13MM BALLOON AT 18 ATM BECAUSE THE STENT WAS NOT FULLY EXPANDED. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. PRE AND POST-PROCEDURE THROMBIN INHIBITION IN MYOCARDIAL INFARCTION (TIMI) FLOWS WERE NOT DOCUMENTED. INTRA-VASCULAR ULTRASOUND (IVUS) WAS NOT USED. PCI WAS PERFORMED NEXT ON A 70% DE NOVO LESION IN THE PROXIMAL LAD OF 28MM IN LENGTH IN A 3.00MM VESSEL DIAMETER. THE (B1) ECCENTRIC LESION WAS CHARACTERIZED WITH A SMOOTH CONTOUR, MODERATE CALCIFICATION AND THROMBUS ABSENT. THE LESION WAS PRE-DILATED WITH A 3.25X8MM BALLOON AT 20 ATM BEFORE A 3.0X28MM CYPHER SELECT PLUS STENT WAS DEPLOYED AT 10 ATM WITH SATISFACTORY RESULTS. THIS STENT OVERLAPPED THE PREVIOUSLY DEPLOYED STENT IN THE MID LAD. POST-DILATION WAS DONE WITH A 3.25X8MM BALLOON AT 20 ATM BECAUSE THE STENT WAS NOT FULLY EXPANDED. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. PRE AND POST-PROCEDURE THROMBIN INHIBITION IN MYOCARDIAL INFARCTION (TIMI) FLOWS WERE NOT DOCUMENTED. INTRA-VASCULAR ULTRASOUND (IVUS) WAS NOT USED. POST-PROCEDURE TROPONIN LEVELS WERE 3 AND 2, RESPECTIVELY, DURING THE 6-24 HOUR INTERVAL AND THE 24 HOUR TO DISCHARGE INTERVAL. THIS WAS AN INCREASE UP TO 1,86 MCG/L. THERE WERE NO PROCEDURAL COMPLICATIONS. THE PT WAS DISCHARGED TWO DAYS LATER. POST-PROCEDURE MEDICATIONS INCLUDED PERMANENT ASPIRIN, CLOPIDOGREL FOR 3 MONTHS, STATINS, ACE INHIBITORS AND BETA-BLOCKERS. THE PT COULD NOT BE LOCATED DURING THE 6-MONTH FOLLOW-UP INTERVAL. INFO OBTAINED FROM THE REFERRING CARDIOLOGIST INDICATED THAT THE PT HAD URGENT CARDIAC SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA 13190822

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R POST: PERMANENT ASPIRIN| OTHER LIPID LOWERING MEDICATIONS| BETA-BLOCKERS| ACE INHIBITORS| STATINS| CLOPIDOGREL FOR 3 MONTHS| UNFRACTIONATED HEPARIN| INTRA: CLOPIDOGREL| BETA-BLOCKERS| STATINS| PRE-PROCEDURE MEDICATIONS: ASPIRIN| CLOPIDOGREL